specifications is an important tool for selecting the right CRO for a project and for successfully managing the relationship with that CRO during the project. (See sample outline.)
The process of preparing study specifications is a multi-disciplinary one involving a team of specialists from within the company who can address the various aspects of the study, such as protocol development, case report design, database design, study locations and so forth. In certain cases (such as when a decision about which CRO to use has already been made, based on past experience with the CRO), the CRO itself may even be a part of the team that prepares the specifications. By making the CRO a part of the process when appropriate, the sponsor can be sure that the CRO fully understands the scope and demands of the project, since it will have been involved in the process of establishing them.
Sample Outline of Specifications for a Clinical Study
A. Description of the product
1. Generic name
2. Dose form
3. Projected therapeutic indication
B. Details of the study
1. Study objective
2. Experimental design
3. Patient population
4. Projected dropout rate
5. Total number of patients
6. Statistical power
7. Clinical setting
8. Number of clinical sites
C. Regulatory status
1. Purpose of the study
2. Regulatory phase
3. Type of regulatory submission
D. Materials and service
1. Prepare study materials (list specific activities)
